Lab design as per GLP/GMP compliance

Qualification of equipment / instrument etc.,

Sampling plan, testing, approving / rejecting system – RM & PM, Intermediate, in-process (IPQC), FP & labeling components

Validation of analytical methods

Calibration & Reference standards program

Documentation (specs, test methods, reports, chromatograms, data sheets / raw data note books, 21 CFR part 11 – electronic records control, overall GLP, GDP etc.,)

Data integrity – ALCOA & OOS handling

Microbiology & water system etc.,

Training/qualification of personnel/Analyst.

Calibration and maintenance programs for analytical instruments and equipment.

Validation and security of computerized or automated processes.

Test methods for establishing a complete impurity profile for each API process

Adequate reserve samples; documentation of reserve samples examination.

Stability testing program, including demonstration of stability indicating capability of the test methods.

Compliance audits with respect to GMP, GLP, OECD and ICH

Good quality control laboratory practices review assessment